Rheumatoid Arthritis, NOSPhase 2NCT00605735
PoC in Rheumatoid Arthritis With Methotrexate
A Phase 2 study testing BMS-582949 in people with Rheumatoid Arthritis, NOS, run by Bristol-Myers Squibb at 28 sites in 8 countries.
Trial summary
The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, NOS
- What is being tested?
- BMS-582949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 28 sitesin 8 countries
- Study dates
- Mar 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of RA for at least 6 months
- Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
- Must have at least 6 swollen and at least 8 tender joints
- CRP above upper limit of normal or ESR > 28 mm/hr
- Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication
Who cannot join
- Any infection including TB, HIV, Hepatitis B or C
- Recent infection requiring antibiotics within 4 weeks
- History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
- Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
United States8 sites
Walter F Chase Md
Austin, Texas, 78705
Arthritis Clinic
Jackson, Tennessee, 38305
G. Timothy Kelly, Md
Las Vegas, Nevada, 81928
Health Research Of Oklahoma
Oklahoma City, Oklahoma, 73103
Desert Medical Advances
Palm Desert, California, 92260
The Arthritis Group
Philadelphia, Pennsylvania, 19152
Orrin M. Troum,M D
Santa Monica, California, 90404
Tacoma Center For Arthritis Research Ps
Tacoma, Washington, 98405
Mexico5 sites
Local Institution
Culiacán, Sinaloa, 8000
Local Institution
Guadalajara, Jalisco, 44200
Local Institution
Guadalajara, Jalisco, 44500
Local Institution
Mexico City, Mexico City, 14080
Local Institution
Nuevo León, Nuevo León, 64020
Argentina3 sites
Local Institution
Buenos Aires, Buenos Aires, 1426
Local Institution
Capital Federal, Buenos Aires, 1431
Local Institution
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1034ACO
Czechia3 sites
Local Institution
České Budějovice, 370 01
Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 128 50
France3 sites
Local Institution
Bordeaux, 33076
Local Institution
Chambray-lès-Tours, 37170
Local Institution
Paris, 75679
Spain3 sites
Local Institution
Madrid, 28046
Local Institution
Santiago de C., 15706
Local Institution
Vizcaya, 48903
About this study
Official title: A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate
The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate
- Conditions
- Rheumatoid Arthritis, NOS
- Being tested
- BMS-582949, Placebo
- Medical subject headings
- Arthritis, Rheumatoid, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-582949Drug
Also called P38 Inflamation
Tablets, Oral, 300 mg, once daily, 12 weeks
PlaceboDrug
Tablets, Oral, placebo, once daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Not described Receives: Drug: BMS-582949 |
| P1 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
Measured: at Week 12
Secondary outcomes (7)
Proportion of subjects achieving an ACR 20
Measured: at each scheduled visit
Proportion of subjects schieving and ACR 50
Measured: at each scheduled visit
Proportion of subjects schieving and ACR 70
Measured: at each scheduled visit
Percent change from baseline to each scheduled visit in DAS28 score
Measured: at each scheduled visit
Percent change from baseline to each scheduled visit in ACR scores
Measured: at each scheduled visit
Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue
Measured: at each scheduled visit
Percent change from baseline to each scheduled visit in HAQ score
Measured: at each scheduled visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis, NOSStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605735
- Sponsor's protocol ID
- IM119-015
- Status last verified
- Sep 2015
- First submitted
- 18 Jan 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT00605735
- Acronym / sponsor ID
- IM119-015
- Conditions
- Rheumatoid Arthritis, NOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: BMS-582949 |
| P1 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have a diagnosis of RA for at least 6 months
- Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
- Must have at least 6 swollen and at least 8 tender joints
- CRP above upper limit of normal or ESR > 28 mm/hr
- Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication
Key exclusion criteria (4 listed)
- Any infection including TB, HIV, Hepatitis B or C
- Recent infection requiring antibiotics within 4 weeks
- History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
- Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-582949Also: P38 InflamationTablets, Oral, 300 mg, once daily, 12 weeks | Drug | A1 |
| PlaceboTablets, Oral, placebo, once daily, 12 weeks | Drug | P1 |
Primary outcome
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
Time frame: at Week 12
7 secondary outcomes
Proportion of subjects achieving an ACR 20
Time frame: at each scheduled visit
Proportion of subjects schieving and ACR 50
Time frame: at each scheduled visit
Proportion of subjects schieving and ACR 70
Time frame: at each scheduled visit
Percent change from baseline to each scheduled visit in DAS28 score
Time frame: at each scheduled visit
Percent change from baseline to each scheduled visit in ACR scores
Time frame: at each scheduled visit
Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue
Time frame: at each scheduled visit
Percent change from baseline to each scheduled visit in HAQ score
Time frame: at each scheduled visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-582949 in people with Rheumatoid Arthritis, NOS, run by Bristol-Myers Squibb at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Mexico, Argentina, Czechia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 (time frame: at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.